FDA and CDC, along with state and local officials, are continuing to investigate the multi-state outbreak of cyclosporiasis illnesses likely linked to salads from McDonald's restaurants. As of August 2, 2018, a total of 395 laboratory-confirmed cases of Cyclospora infection were reported in people who consumed salads from McDonald’s; the cases were reported by 15 states. (The Connecticut, Tennessee, and Virginia case-patients purchased salads while traveling in Illinois; the Florida case-patient purchased a salad while traveling in Kentucky.)

On July 26, 2018, the FDA completed final analysis of an unused package of Fresh Express salad mix containing romaine lettuce and carrots, which had been distributed to McDonald's. The analysis confirmed the presence of Cyclospora in that sample, though the expiration date for that product, July 19, had already passed. On July 27, the FDA informed Fresh Express of the results.

FDA instructed Fresh Express to determine whether potentially contaminated product may still be on the market. Fresh Express reported to FDA that the romaine from the same lot as the positive sample was not packaged for direct retail sale by Fresh Express and had already expired. Fresh Express committed to using recall procedures to inform those companies that received this romaine about the sample result. Fresh Express also reported that carrots used in the mix were only sent to McDonald's locations.

On July 30, 2018, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) issued a public health alert on beef, pork and poultry salad and wrap products potentially contaminated with Cyclospora that were distributed by Caito Foods LLC, of Indianapolis, IN. The products were produced between July 15 and 18, 2018, with either “Best By,” “Enjoy by,” “Best if Sold By” or “Sell By” dates ranging from July 18 through July 23, 2018. Caito Foods had received notification from Fresh Express that the chopped romaine in these products was being recalled.

The CDC reports that 395 people in 15 states have become ill. There have been 16 hospitalizations and no deaths.

The investigation is ongoing and the FDA is currently reviewing distribution and supplier information for romaine and carrots.

As of July 13, 2018, McDonald's decided to voluntarily stop selling salads at impacted restaurants in West Virginia, Kentucky, Missouri, Illinois, Iowa, Indiana, Michigan, Ohio, Nebraska, Wisconsin, Minnesota, South Dakota, North Dakota, and Montana. The company has since reported that it has replaced the supplier of salads in those states. More information can be found in McDonald's Statement.

Consumers who have symptoms of cyclosporiasis should contact their health care provider to report their symptoms and receive care. Most people infected with Cyclospora develop diarrhea, with frequent, sometimes explosive, bowel movements. Other common symptoms include loss of appetite, weight loss, stomach cramps/pain, bloating, increased gas, nausea, and fatigue. Vomiting, body aches, headache, fever, and other flu-like symptoms may be noted. Some people who are infected with Cyclospora do not have any symptoms. If not treated, the illness may last from a few days to a month or longer. Symptoms may seem to go away and then return one or more times (relapse).

Hygiena Completes Acquisition of Biomedal Diagnostics Food Safety

Hygiena, a Camarillo-Calif., Warburg Pincus-portfolio company that specializes in rapid food safety and environmental sanitation testing, has acquired Biomedal’s Food Safety division from Seville, Spain-based Biomedal. The division offers a wide range of allergen tests including the GlutenTox product line which contains the highly specific G12 antibody which detects the most immunogenic component that is responsible for gluten intolerance, the company said. GlutenTox Pro holds the certification of the AOAC Research Institute for Performance Tested methods (certificate no. 061502).

The new division will continue to be based in Seville, and will be named Hygiena Diagnóstica España S.L. It will provide more than 20 specific allergen tests available as a sensitive enzyme linked immunosorbent assay (ELISA) format or a simple dipstick format that can be easily used to verify cleaning efforts and test finished products, the company said.

“We are excited to welcome the new team to Hygiena and look forward to serving our global food and beverage customers with a wider food safety testing portfolio,” said Steven Nason, Chief Executive Officer of Hygiena “Our allergen business has been growing rapidly and customers around the world have been asking us for a wider array of allergen tests. With this acquisition of Biomedal Food Safety, we now offer an allergen line that is best in class. We will continue investing in new product research and development and further expand our allergen product portfolio.”

Biomedal Food Safety employees will become employees of Hygiena, and the division’s products will continue to be available through its existing distribution network. The Biomedal Food Safety division is a leading provider of allergen tests to top food processors and its sales growth has averaged 25% over the last 5 years.

Should Soy, Almond, and Rice “Milk” Be Labeled as Milk?

“Food labels – including the name of food – inform consumers about what they’re buying, and standards of identity are used to ensure that foods have the characteristics expected by consumers,” wrote FDA Commissioner Scott Gottlieb, M.D., in a July 26 statement on the process FDA is undertaking for reviewing and modernizing its standards of identity for dairy products. “The information provided through food labeling must be truthful and not misleading. The consumer choices made based on this information can have important impacts on health.”

Following is Gottlieb’s discussion on review of plant-based foods positioned as substitutes for standardized dairy products:

“One area that needs greater clarity – and which has been the subject of much discussion of late – is the wide variety of plant-based foods that are being positioned in the marketplace as substitutes for standardized dairy products. Many of these plant-based foods use traditional dairy terms (e.g., milk, yogurt, cheese) in the name of the product. For instance, we’ve seen a proliferation of products made from soy, almond or rice calling themselves milk. However, these alternative products are not the food that has been standardized under the name “milk” and which has been known to the American public as “milk” long before the 1938 Federal Food, Drug, and Cosmetic Act (FD&C Act) was established. In addition, some of these products can vary widely in their nutritional content – for instance in relation to inherent protein or in added vitamin content – when compared to traditional milk.

“We intend to look at these differences in relation to potential public health consequences. There are reports that indicate this issue needs examination. For example, case reports show that feeding rice-based beverages to young children resulted in a disease called kwashiorkor, a form of severe protein malnutrition. There has also been a case report of a toddler being diagnosed with rickets, a disease caused by vitamin D deficiency, after parents used a soy-based alternative to cow’s milk. Because these dairy alternative products are often popularly referred to as ‘‘milk,’’ we intend to look at whether parents may erroneously assume that plant-based beverages’ nutritional contents are similar to those of cow’s milk, despite the fact that some of these products contain only a fraction of the protein or other nutrients found in cow’s milk.

“We hope that the examination of this issue will demonstrate whether future cases of kwashiorkor or rickets may be prevented by changes to the labeling of these products, as well as by the education of physicians and parents about the nutritional content of these beverages. Such public health concerns are one of the reasons why we’re prioritizing this effort to take a closer look at the standards of identity for dairy products as part of our overall process for modernizing our standards of identity and advancing the information consumers have to inform their diets.

“We will not be doing this in a vacuum. We’re going to have an active public process for reviewing our standard and how consumers understand the use of terms like milk on both animal-derived and plant-based products. We want to see if the nutritional characteristics and other differences between these products are well-understood by consumers when making dietary choices for themselves and their families. We must better understand if consumers are being misled as a result of the way the term milk is being applied and making less informed choices as a result.

“We also are actively looking at how we have been enforcing the FD&C Act with respect to food names and our own standard of identity for milk and what it means when milk is qualified with words like almond or soy. We recognize that, as a regulatory agency, it’s not appropriate to unilaterally change our regulatory approach if we have a history of non-enforcement. We also need to closely consider the potential First Amendment issues related to the different uses of these terms.

“This week we will start the process of modernizing our standards of identity broadly by gathering stakeholder feedback at our Nutrition Innovation Strategy Public Meeting. We encourage all interested stakeholders to continue to submit comments to the docket for this meeting. We’ll be reviewing the information gathered and posting an additional request for information, likely in the late summer or early fall, with a specific set of questions pertaining to consumer awareness and understanding of the use of milk and other dairy terms on plant-based alternatives, with a focus on nutritional impact. The feedback we receive will help inform a revisiting of our policy for these terms. Over the next year, we will be looking at next steps which will likely include issuing guidance for industry and a new compliance policy outlining our enforcement approach.

“In the meantime, we’ll continue to take actions when we become aware of products with misleading labels that have a high likelihood of consumer misunderstanding as to the basic nature of the product, especially when nutrition and therefore public health may be at risk.”

Consumer Spending Surveys May Not Tell Real Story

There are any number of surveys showing that people say they are willing to pay more for foods they see as beneficial, such as natural, organic, etc. However, a new study is showing that people aren’t always willing to pay as much as they say they will when faced with the reality.

When researchers compared what study participants reported they were willing to spend on goods with what they actually shelled out in experiments designed to mimic a real-world shopping experience, there was a big gap. “People said they’d spend about twice as much, on average, as they actually spent when faced with more realistic circumstances,” said co-lead researcher Wuyang Hu of The Ohio State University.

Asking people to estimate how much they’d spend on a good or service is a key part of economics research and the results can drive decision making by business, government leaders and others, said Hu, a professor of agricultural, environmental, and development economics at Ohio State.

“Unfortunately, in many circumstances, it’s extremely difficult to observe people’s actual behavior, so we have to use these hypothetical, made-up scenarios,” Hu said. “The problem is, we know that what people say they will spend and what they actually spend don’t always line up.”

The difference between these two amounts is called “hypothetical bias” and it stands in the way of research that can shape important decisions, like evaluating the worth of cleaning up after an environmental catastrophe, Hu said. In fact, the whole notion of this phenomenon came about after the 1989 Exxon-Valdez oil spill, when lawyers grappled with arriving at the cost of work to soak up the oil and protect animals, plants and natural resources in Alaska.

Hu and his co-author, Jerrod Penn of Louisiana State University, wanted to better understand the discrepancy between what people report they’ll pay and what they’ll actually pay. To do that, they reviewed and summarized results found in previous studies, either published or not. They looked at more than 500 articles and chose 132 studies that included hypothetical questions and an attempt to create a real-life spending experience – such as a classroom set up to look like a store in which study participants had actual money to spend. The study appears in the American Journal of Agricultural Economics.

Overall, the difference between hypothetical spending and real spending was almost twofold. Hu stressed that even this could be an underestimate, given that the “real” spending observations are done under circumstances that attempt to mimic real life.

“Sometimes people are aware they’re being observed. Sometimes they have no idea. But it’s not really a grocery store or a conservation group’s office where you’re making an actual donation. It’s an experiment, so we take those so-called ‘real’ spending observations with a grain of salt as well,” Hu said.

Somewhat surprisingly, the researchers found that student study participants were not less reliable than others – a trend that has emerged in other research and led to concerns about the validity of economics research that relies largely on college students’ feedback about spending.

“Some people have reached the conclusion that because students don’t have much money to spend in real life, they tend to overstate what they’d spend, but we didn’t find that,” Hu said.

The researchers also found evidence that three common techniques designed to mitigate bias were effective: “cheap talk,” certainty follow-up and consequentiality.

Researchers who use the cheap talk approach explicitly address the issue to study subjects, acknowledging that people often claim on surveys that they’ll spend more than they would actually spend in real life. Researchers then tell them not to do that. Cheap talk techniques reduced differences by 41%, the researchers found.

Certainty follow-up involves asking the study participant to rate his or her level of certainty about a given survey response and this method reduced differences by 99%.

Consequentiality is when researchers emphasize the importance and value of the survey participants’ honest responses. This approach reduced differences between hypothetical and real spending by 95%.

Penn, an assistant professor of resource economics at Louisiana State, said the evidence in favor of cheap talk and other efforts to mitigate hypothetical bias is important – especially because some previous studies have cast doubt on the usefulness of such techniques.

“This means that exploring and testing new mitigation methods and how methods can complement each other continues to be a valuable avenue of future research,” Penn said.

Hu said he hopes this robust meta-analysis of prior research will lead to improved techniques for factoring in this hypothetical bias or designing studies that do a better job of reducing it.

“Researchers will benefit from having more information about adjusting their results upward or downward to come closer to the truth about how much people will spend,” Hu said.

He said he’d like to develop an app that researchers could use to estimate the impact of hypothetical bias based on the nature of their study, the participants and whether the good or service being studied is public or private.

“Hypothetical bias is really the tip of the iceberg in the entire human behavior puzzle that everyone’s trying to crack in economics. Hopefully this brings us a little bit closer to the truth,” Hu said.

Tim Jackson Assumes IAFP Presidency

Tim Jackson assumed the presidency of the International Association for Food Protection at the conclusion of IAFP 2018 in Salt Lake City, Utah.

Jackson is vice president of food safety, regulatory compliance and social compliance for Driscoll’s of the Americas in Watsonville, Calif., where he has been since 2017. In this role, Jackson leads the team in North and South America with responsibility for food safety, regulatory (including organic) compliance and compliance in worker welfare. Driscoll’s is a producer of fresh strawberries, blueberries, raspberries, and blackberries.

An IAFP Member since 2001, Jackson has participated in numerous Professional Development Group (PDG) activities, including service as vice chair and chair of the Applied Laboratory Methods PDG. He has volunteered on several committees throughout his membership, including the IAFP Program Committee, and both the Black Pearl Award and the International Leadership Award Selection Committees. He has presented at many IAFP meetings and chaired a key workshop at the IAFP European Symposium on Food Safety in 2006.

Jackson received his B.S. in Biology from Abilene Christian University and his M.S. and Ph.D. in Food Technology – Microbiology from Texas A&M University